Breast Cancer, Ovarian Cancer
Conditions
Keywords
Ovarian Cancer; Breast Cancer, Olaparib
Brief summary
A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum based Chemotherapy and Metastatic Breast Cancer with germline BRCA (BReast CAncer gene) 1/2 Mutation
Detailed description
A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum based Chemotherapy and Metastatic Breast Cancer with germline BRCA(BReast CAncer gene)1/2 Mutation As per recommendation from DCGI(Drug Controller general of of India), the current phase-IV study is planned with the aim to assess the safety in Indian subjects receiving olaparib as per the approved label indications in India in accordance with the requirements of the Health Authorities of India. This study attempts to descriptively elucidate the safety of Olaparib in Indian subjects receiving olaparib as per the Indian regulatory approved indications in India. The data obtained from the present study will help to understand the safety profile of olaparib in Indian patients.
Interventions
DRUGOlaparib
Tablet
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A Prospective, Multicentre, Phase-IV Clinical Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures.. 2. Female Subjects with ≥ 18 years of age 3. Subjects receiving olaparib for the following indications in ovarian cancer: for the maintenance treatment of adult subjects with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy 4. Subjects receiving olaparib for the following indication in breast cancer: in subjects with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Subjects with HR-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment
Exclusion criteria
1. Patients with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug. 2. pregnant and/or lactating women. 3. Patients with a previously or currently diagnosed MDS/ AML or pneumonitis. 4. Patients who have not recovered sufficiently from prior surgery or anticancer treatment. 5. Patients who have known history of hepatitis B or hepatitis C 6. Patients with active infection such as TB. 7. Participation in another clinical study with a study drug administered in the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Baseline to EOT (approximately 6 months) | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Comparison between the cohorts was not the objective for the study. The hematology data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population . EOT = end of treatment |
| Haematology: Haemoglobin Parameters | Baseline to EOT (approximately 6 months) | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. The haemoglobin parameter data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population . EOT = end of treatment |
| Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Baseline to EOT (approximately 6 months) | The number of participants who experienced hematology results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. EOT = end of treatment |
| Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT | Baseline to EOT (approximately 6 months) | The number of participants who experienced hemoglobin results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented.. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. EOT = end of treatment |
| Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator | Baseline to EOT (approximately 6 months) | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Remarkable changes were assessed by the investigator. EOT = end of treatment |
| Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Baseline to EOT (approximately 6 months) | Abnormal clinically significant results at Baseline and EOT are presented. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. |
| Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator | Baseline to EOT (approximately 6 months) | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Remarkable changes were assessed by the investigator. EOT = end of treatment |
| WHO Performance Status | Baseline and End of study visit (200 days) | The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. |
Countries
India
Participant flow
Recruitment details
Participants who were prescribed olaparib by an independent clinical judgement of investigator in his/her routine practice based on locally approved prescribing information were eligible for screening under this study.
Participants by arm
| Arm | Count |
|---|---|
| Ovarian Cancer Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8). | 163 |
| Breast Cancer Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8). | 38 |
| Both Ovarian Cancer and Breast Cancer Olaparib was administered orally at a dose of 300 mg (two 150-mg tablets) twice a day in all cohorts from Day 1 (Visit 2) to Day 182 (+/- 3 days; Visit 8). | 1 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 1 | 0 |
| Overall Study | Disease progression | 38 | 10 | 0 |
| Overall Study | Enrolled and did not receive study drug (not included in Safety Analysis Set) | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Other: Adverse event | 5 | 0 | 0 |
| Overall Study | Other: Disease progression | 1 | 0 | 0 |
| Overall Study | Other: Due to anemia the investigator decided not to continue | 1 | 0 | 0 |
| Overall Study | Other: Due to disease progression and could not tolerate the dose | 1 | 0 | 0 |
| Overall Study | Other: Increased QTc interval and clinical progression found | 0 | 1 | 0 |
| Overall Study | Other: Progressive disease (no confirming documents) | 0 | 1 | 0 |
| Overall Study | Physician Decision | 5 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Ovarian Cancer | Both Ovarian Cancer and Breast Cancer | Breast Cancer |
|---|---|---|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 10.01 | 53.2 years STANDARD_DEVIATION 8.78 | 57.0 years | 44.3 years STANDARD_DEVIATION 11.85 |
| Body mass index | 25.896 kg/m2 STANDARD_DEVIATION 4.6 | 26.204 kg/m2 STANDARD_DEVIATION 4.5366 | 21.210 kg/m2 | 24.699 kg/m2 STANDARD_DEVIATION 4.7282 |
| Child Bearing Potential No | 189 Participants | 162 Participants | 1 Participants | 26 Participants |
| Child Bearing Potential Yes | 13 Participants | 1 Participants | 0 Participants | 12 Participants |
| Previous Cancer Therapy 1 cancer therapy regimen | 10 Participants | 2 Participants | 0 Participants | 8 Participants |
| Previous Cancer Therapy 2 cancer therapy regimens | 66 Participants | 55 Participants | 1 Participants | 10 Participants |
| Previous Cancer Therapy More than 2 cancer therapy regimens | 125 Participants | 106 Participants | 0 Participants | 19 Participants |
| Previous Cancer Therapy No | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Sex: Female, Male Female | 202 Participants | 163 Participants | 1 Participants | 38 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Stage/FIGO Stage of Cancer at Screening Missing | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Stage/FIGO Stage of Cancer at Screening Stage IA | 6 Participants | 4 Participants | 0 Participants | 2 Participants |
| Stage/FIGO Stage of Cancer at Screening Stage IB | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Stage/FIGO Stage of Cancer at Screening Stage IC | 5 Participants | 5 Participants | 0 Participants | 0 Participants |
| Stage/FIGO Stage of Cancer at Screening Stage IIA | 4 Participants | 1 Participants | 0 Participants | 3 Participants |
| Stage/FIGO Stage of Cancer at Screening Stage IIB | 3 Participants | 2 Participants | 0 Participants | 1 Participants |
| Stage/FIGO Stage of Cancer at Screening Stage IIIA | 15 Participants | 12 Participants | 0 Participants | 3 Participants |
| Stage/FIGO Stage of Cancer at Screening Stage IIIB | 9 Participants | 6 Participants | 0 Participants | 3 Participants |
| Stage/FIGO Stage of Cancer at Screening Stage IIIC | 69 Participants | 60 Participants | 0 Participants | 9 Participants |
| Stage/FIGO Stage of Cancer at Screening Stage IVA | 53 Participants | 42 Participants | 1 Participants | 10 Participants |
| Stage/FIGO Stage of Cancer at Screening Stage IVB | 35 Participants | 29 Participants | 0 Participants | 6 Participants |
| WHO Performance Status 100% bedridden | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| WHO Performance Status In bed less than or equal to 50% of the time | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| WHO Performance Status In bed more than 50% of the time | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| WHO Performance Status Normal activity | 196 Participants | 157 Participants | 1 Participants | 38 Participants |
| WHO Performance Status Restricted activity | 6 Participants | 6 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 161 | 3 / 38 | 0 / 1 |
| other Total, other adverse events | 148 / 161 | 30 / 38 | 1 / 1 |
| serious Total, serious adverse events | 24 / 161 | 7 / 38 | 1 / 1 |
Outcome results
Primary
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Comparison between the cohorts was not the objective for the study. The hematology data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population . EOT = end of treatment
Time frame: Baseline to EOT (approximately 6 months)
Population: The safety analysis set included all participants who received the study drug (200 overall).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Above Normal | 0 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Below Normal | 43 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Missing | 31 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Above Normal | 2 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Above Normal | 2 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Above Normal | 3 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Normal | 84 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Below Normal | 51 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Missing | 48 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Below Normal | 26 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Normal | 90 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Normal | 69 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Below Normal | 21 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Missing | 31 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Missing | 48 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Below Normal | 41 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Above Normal | 18 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Above Normal | 2 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Normal | 101 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Missing | 31 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Below Normal | 27 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Missing | 31 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Missing | 48 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Below Normal | 21 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Above Normal | 0 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Normal | 79 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Normal | 72 Participants |
| Ovarian | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Normal | 107 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Below Normal | 7 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Below Normal | 16 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Missing | 15 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Above Normal | 1 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Below Normal | 6 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Missing | 12 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Above Normal | 0 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Missing | 12 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Above Normal | 1 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Above Normal | 1 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Above Normal | 0 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Missing | 15 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Below Normal | 10 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Normal | 14 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Missing | 12 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Missing | 16 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Normal | 17 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Below Normal | 8 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Normal | 12 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Normal | 13 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Missing | 12 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Normal | 20 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Above Normal | 0 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Normal | 19 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Normal | 10 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Below Normal | 3 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Below Normal | 8 Participants |
| Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Above Normal | 6 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Normal | 1 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Above Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Normal | 1 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Below Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Missing | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Above Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Normal | 1 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Below Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Missing | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Above Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Normal | 1 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Below Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Missing | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Above Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Below Normal | 1 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Missing | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Above Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Below Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Missing | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Above Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Normal | 1 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Below Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Missing | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Above Normal | 1 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Below Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Missing | 0 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Normal | 89 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Above Normal | 0 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Below Normal | 51 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Normal | 127 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Missing | 43 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Below Normal | 35 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Missing | 43 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Below Normal | 27 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Normal | 119 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Leucocytes WBC | EOT Above Normal | 3 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Below Normal | 50 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Missing | 43 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Missing | 63 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Below Normal | 24 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Normal | 85 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Above Normal | 25 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Normal | 111 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Eosinophils Absolute Count | EOT Above Normal | 2 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Above Normal | 0 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Below Normal | 34 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Normal | 99 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Above Normal | 4 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Platelets | EOT Normal | 82 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Monocytes Absolute Count | EOT Missing | 63 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Missing | 43 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Lymphocytes Absolute Count | EOT Below Normal | 68 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Basophils Absolute Count | EOT Missing | 64 Participants |
| Cancer Type: Overall | Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters | Neutrophils Absolute Count | EOT Above Normal | 3 Participants |
Primary
Haematology: Haemoglobin Parameters
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. The haemoglobin parameter data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population . EOT = end of treatment
Time frame: Baseline to EOT (approximately 6 months)
Population: The safety analysis set included all participants who received the study drug (200 overall).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovarian | Haematology: Haemoglobin Parameters | EOT Above Normal | 0 Participants |
| Ovarian | Haematology: Haemoglobin Parameters | EOT Normal | 15 Participants |
| Ovarian | Haematology: Haemoglobin Parameters | EOT Below Normal | 115 Participants |
| Ovarian | Haematology: Haemoglobin Parameters | EOT Missing | 31 Participants |
| Breast Cancer | Haematology: Haemoglobin Parameters | EOT Normal | 5 Participants |
| Breast Cancer | Haematology: Haemoglobin Parameters | EOT Below Normal | 21 Participants |
| Breast Cancer | Haematology: Haemoglobin Parameters | EOT Missing | 12 Participants |
| Breast Cancer | Haematology: Haemoglobin Parameters | EOT Above Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Haemoglobin Parameters | EOT Below Normal | 1 Participants |
| Both Ovarian and Breast Cancer | Haematology: Haemoglobin Parameters | EOT Normal | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Haemoglobin Parameters | EOT Missing | 0 Participants |
| Both Ovarian and Breast Cancer | Haematology: Haemoglobin Parameters | EOT Above Normal | 0 Participants |
| Cancer Type: Overall | Haematology: Haemoglobin Parameters | EOT Missing | 43 Participants |
| Cancer Type: Overall | Haematology: Haemoglobin Parameters | EOT Normal | 20 Participants |
| Cancer Type: Overall | Haematology: Haemoglobin Parameters | EOT Above Normal | 0 Participants |
| Cancer Type: Overall | Haematology: Haemoglobin Parameters | EOT Below Normal | 137 Participants |
Primary
Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT
The number of participants who experienced hematology results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. EOT = end of treatment
Time frame: Baseline to EOT (approximately 6 months)
Population: The safety analysis set included all participants who received the study drug (200 overall).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ovarian | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Platelets | 23 Participants |
| Ovarian | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Leucocytes WBC | 17 Participants |
| Ovarian | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Eosinophils Absolute Count | 8 Participants |
| Ovarian | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Basophils Absolute Count | 13 Participants |
| Ovarian | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Monocytes Absolute Count | 21 Participants |
| Ovarian | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Lymphocytes Absolute Count | 20 Participants |
| Ovarian | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Neutrophils Absolute Count | 9 Participants |
| Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Lymphocytes Absolute Count | 8 Participants |
| Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Monocytes Absolute Count | 6 Participants |
| Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Eosinophils Absolute Count | 2 Participants |
| Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Platelets | 4 Participants |
| Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Leucocytes WBC | 6 Participants |
| Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Neutrophils Absolute Count | 5 Participants |
| Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Basophils Absolute Count | 5 Participants |
| Both Ovarian and Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Basophils Absolute Count | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Eosinophils Absolute Count | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Leucocytes WBC | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Lymphocytes Absolute Count | 1 Participants |
| Both Ovarian and Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Monocytes Absolute Count | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Neutrophils Absolute Count | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Platelets | 0 Participants |
| Cancer Type: Overall | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Leucocytes WBC | 23 Participants |
| Cancer Type: Overall | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Platelets | 27 Participants |
| Cancer Type: Overall | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Neutrophils Absolute Count | 14 Participants |
| Cancer Type: Overall | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Eosinophils Absolute Count | 10 Participants |
| Cancer Type: Overall | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Basophils Absolute Count | 18 Participants |
| Cancer Type: Overall | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Monocytes Absolute Count | 27 Participants |
| Cancer Type: Overall | Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT | Lymphocytes Absolute Count | 29 Participants |
Primary
Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT
The number of participants who experienced hemoglobin results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented.. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. EOT = end of treatment
Time frame: Baseline to EOT (approximately 6 months)
Population: The safety analysis set included all participants who received the study drug (200 overall).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ovarian | Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT | 17 Participants |
| Breast Cancer | Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT | 11 Participants |
| Both Ovarian and Breast Cancer | Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT | 0 Participants |
| Cancer Type: Overall | Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT | 28 Participants |
Primary
Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Remarkable changes were assessed by the investigator. EOT = end of treatment
Time frame: Baseline to EOT (approximately 6 months)
Population: The safety analysis set included all participants who received the study drug (200 overall).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ovarian | Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator | 0 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator | 0 Participants |
Primary
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Abnormal clinically significant results at Baseline and EOT are presented. The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.
Time frame: Baseline to EOT (approximately 6 months)
Population: Safety Analysis Set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Abdomen | 0 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | General Appearance | 0 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Respiratory | 0 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Cardiovascular | 0 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Physical Examination Status | 0 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Lymph Nodes | 0 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Musculoskeletal system | 0 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | No response | 161 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Physical Examination Status | 2 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | General Appearance | 0 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Respiratory | 1 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Cardiovascular | 0 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Abdomen | 1 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Lymph Nodes | 0 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Musculoskeletal system | 0 Participants |
| Ovarian | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | No response | 157 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Lymph Nodes | 0 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Musculoskeletal system | 1 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | No response | 37 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Lymph Nodes | 1 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Physical Examination Status | 1 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | General Appearance | 0 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | No response | 35 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Respiratory | 1 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Physical Examination Status | 0 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Musculoskeletal system | 0 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | General Appearance | 0 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Cardiovascular | 0 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Respiratory | 0 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Cardiovascular | 0 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Abdomen | 0 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Abdomen | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Respiratory | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Lymph Nodes | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Abdomen | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Respiratory | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Musculoskeletal system | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | No response | 1 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Physical Examination Status | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | No response | 1 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Cardiovascular | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Abdomen | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Physical Examination Status | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Lymph Nodes | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | General Appearance | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | General Appearance | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at Baseline | Cardiovascular | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator | Abnormal Clinically Significant result at End of Treatment | Musculoskeletal system | 0 Participants |
Primary
Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Remarkable changes were assessed by the investigator. EOT = end of treatment
Time frame: Baseline to EOT (approximately 6 months)
Population: The safety analysis set included all participants who received the study drug (200 overall).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ovarian | Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator | 0 Participants |
| Breast Cancer | Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator | 0 Participants |
| Both Ovarian and Breast Cancer | Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator | 0 Participants |
Primary
WHO Performance Status
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.
Time frame: Baseline and End of study visit (200 days)
Population: The safety analysis set included all participants who received the study drug (200 overall).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Ovarian | WHO Performance Status | Baseline | In bed less than or equal to 50% of the time | 0 Participants |
| Ovarian | WHO Performance Status | Baseline | Normal activity | 155 Participants |
| Ovarian | WHO Performance Status | Baseline | Restricted activity | 6 Participants |
| Ovarian | WHO Performance Status | End of Study | Normal activity | 92 Participants |
| Ovarian | WHO Performance Status | End of Study | Restricted activity | 7 Participants |
| Ovarian | WHO Performance Status | End of Study | In bed less than or equal to 50% of the time | 1 Participants |
| Breast Cancer | WHO Performance Status | End of Study | Restricted activity | 1 Participants |
| Breast Cancer | WHO Performance Status | Baseline | In bed less than or equal to 50% of the time | 0 Participants |
| Breast Cancer | WHO Performance Status | Baseline | Normal activity | 38 Participants |
| Breast Cancer | WHO Performance Status | End of Study | In bed less than or equal to 50% of the time | 0 Participants |
| Breast Cancer | WHO Performance Status | End of Study | Normal activity | 12 Participants |
| Breast Cancer | WHO Performance Status | Baseline | Restricted activity | 0 Participants |
| Both Ovarian and Breast Cancer | WHO Performance Status | End of Study | Restricted activity | 0 Participants |
| Both Ovarian and Breast Cancer | WHO Performance Status | End of Study | In bed less than or equal to 50% of the time | 0 Participants |
| Both Ovarian and Breast Cancer | WHO Performance Status | Baseline | In bed less than or equal to 50% of the time | 0 Participants |
| Both Ovarian and Breast Cancer | WHO Performance Status | End of Study | Normal activity | 0 Participants |
| Both Ovarian and Breast Cancer | WHO Performance Status | Baseline | Normal activity | 1 Participants |
| Both Ovarian and Breast Cancer | WHO Performance Status | Baseline | Restricted activity | 0 Participants |
| Cancer Type: Overall | WHO Performance Status | Baseline | Normal activity | 194 Participants |
| Cancer Type: Overall | WHO Performance Status | Baseline | Restricted activity | 6 Participants |
| Cancer Type: Overall | WHO Performance Status | Baseline | In bed less than or equal to 50% of the time | 0 Participants |
| Cancer Type: Overall | WHO Performance Status | End of Study | Normal activity | 104 Participants |
| Cancer Type: Overall | WHO Performance Status | End of Study | Restricted activity | 8 Participants |
| Cancer Type: Overall | WHO Performance Status | End of Study | In bed less than or equal to 50% of the time | 1 Participants |